1 General issues and legal aspects
Evidence-based practice
Evidence-based surgery is not restricted to randomised trials and meta-analyses but involves tracking down the best external evidence available to answer clinical questions or problems (see Box 1.1). For example, to find out about the accuracy of a diagnostic test, we need to find proper, cross-sectional studies of patients clinically suspected of harbouring the relevant problem and not a randomised trial. Proper follow-up studies of patients inform about prognosis. Systematic review of several randomised trials (meta-analysis) is much more likely to inform about therapy and whether it does more good than harm.
Box 1.1 Examples of classification systems for levels of evidence
The GRADE Working Group, 2004
High = Further research is very unlikely to change our confidence in the estimate of effect.
Moderate = Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low = Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
United States Preventive Services Task Force, 1989
Level I: Evidence obtained from at least one properly designed randomised controlled trial
Level II-1: Evidence obtained from well-designed controlled trials without randomisation
Level II-2: Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one centre or research group
Level II-3: Evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled trials might also be regarded as this type of evidence
Level III: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees
National Health Service
Level A: Consistent randomised controlled clinical trial, cohort study, all or none, clinical decision rule validated in different populations
Level B: Consistent retrospective cohort, exploratory cohort, ecological study, outcomes research, case-control study; or extrapolations from level A studies
Level C: Case-series study or extrapolations from level B studies
Level D: Expert opinion without explicit critical appraisal, or based on physiology, bench research or first principles
Clinical governance and audit
Clinical governance
A widely used definition of clinical governance is:
• clinical effectiveness activities including audit and redesign
Healthcare organisations should achieve good clinical governance by:
The National Institute for Health and Clinical Excellence (NICE)
This is an NHS organisation set up in 1999 to ensure everyone has equal access to medical treatments and high quality care from the NHS. It is responsible for providing national guidance for promotion of good health and for the prevention and treatment of ill health. These are often referred to as ‘NICE guidelines’; these are easily accessible via www.guidance.nice.org.uk.